BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)

    MDR report key: 18839796 · Received March 5, 2024

    Report

    Report Number
    2135147-2024-01001
    Event Type
    Injury
    Date Received
    March 5, 2024
    Date of Event
    February 13, 2024
    Report Date
    April 12, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    UDI-DI
    08717648230967
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    ALL AVAILABLE INFORMATION WAS INVESTIGATED, AND THE REPORTED LEAKING CLIP INTRODUCER WAS CONFIRMED VIA RETURNED DEVICE ANALYSIS. ADDITIONALLY, A TORN CLIP INTRODUCER VALVE AND MISSING SILICONE FLUID WERE OBSERVED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR COMPLAINTS REPORTED FROM THIS LOT. BASED ON AVAILABLE INFORMATION AND THE RETURNED DEVICE ANALYSIS, THE REPORTED LEAK/SPLASH WAS A CASCADING EVENT OF THE OBSERVED TORN CLIP INTRODUCER VALVE. THE INVESTIGATION DETERMINED THE OBSERVED TORN CLIP INTRODUCER VALVE AND MISSING SILICONE FLUID TO BE RELATED TO A POTENTIAL PRODUCT QUALITY ISSUE. THE REPORTED UNEXPECTED MEDICAL INTERVENTION WAS A RESULT OF CASE-SPECIFIC CIRCUMSTANCES. PER (B)(4), REVISION F, THIS COMPLAINT IS WITHIN THE SCOPE OF AN EXCEPTION ESCALATION AS THE COMPLAINT DESCRIPTION AND DEVICE CODE MATCH THE SPECIFIC ISSUE DESCRIBED IN THE EXCEPTION. THEREFORE, EXCEPTION (ISSUE) 126748 AND EXCEPTION (ACTION) 131415 ARE REFERENCED. THE INVESTIGATION EVALUATED THE REPORTED ISSUE, AND THE ENGINEERING GROUP DETERMINED THE ROOT CAUSE TO BE MAN FOR THE MISSING SILICONE AND THEREFORE, THE TORN CLIP INTRODUCER VALVE AS THE OPERATORS INADVERTENTLY MISSED THE SILICONE VERIFICATION. THE ISSUE IS BEING ADDRESSED PER INTERNAL OPERATING PROCEDURES. ABBOTT WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES.

    Description of Event or Problem · 0

    IT WAS REPORTED THIS WAS A MITRACLIP TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4. THE STEERABLE GUIDE CATHETER (SGC) WAS INSERTED WITHOUT ISSUES. HOWEVER, WHEN THE CLIP DELIVERY SYSTEM (CDS) WAS INSERTED INTO THE SGC HEMOSTATIC VALVE, AIR WAS OBSERVED IN THE SGC. THIS OCCURRED MULTIPLE TIMES; THEREFORE, THE SGC AND CDS WERE REMOVED AND REPLACED. IT WAS NOTED THE LEAK WAS MORE THAN LIKELY CAUSED BY THE CDS. ONE CLIP WAS THEN SUCCESSFULLY IMPLANTED, REDUCING MR TO A GRADE OF <1. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165820 MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD) MITRAL VALVE REPAIR DEVICES NKM ABBOTT MEDICAL 30629R1032 08717648230967

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention STEERABLE GUIDE CATHETER